0133: The first human experience with novel nano surface modified Cobra PzF stent

Abstract

Stenting options for patients at high risk of bleeding (elderly, AF, ACS) are sub-optimal. BMS are not as effective as DES in reducing restenosis but DES require long term DAPT, which increases bleeding risk. Recent animal studies have demonstrated that the nano PzF surface modified stent (Cobra PzF, CeloNova) is thrombo-resistant, and is associated with a rapid reendothelialization. 100 patients (71 men) with mean age 71.4±2 year old of all comer patients were prospectively included to evaluate the safety and the efficacy of the Cobra PzF stent. Patients presented with multiple co-morbidities including 22% DM, 10% AF, 17% EF<40%, 10% VKA, 28% ACS, 10% STEMI and 26% diffused and multivessel diseases. 166 Cobra PzF stents were implanted in 151 lesions (74% B1 lesions) via a radial route (72%) with a 6F-guiding catheter. 1.66 stent/pt was implanted for a mean stent length of 18.7± 0.5mm and a mean diameter of 3.1±0.3mm. Target lesions in left main (2%), LAD Diag (43%), CxMg (23%), RCA (32%), including bifurcated kissed lesions (12%) were treated with 50% direct stenting. The device was successfully implanted in 100% of targeted lesions to achieve a complete revascularization in all cases. In-hospital, there were no adverse events (Death, MI, TLR, cerebral events, stent thrombosis) or incidence of major bleeding complications or transfusions. At one month, no events were reported. 6-month results showed 4% of MACE (terminal cardiac insufficiency and 3 restenosis successfully treated). Those Results are very promising in real world and complex patients (Diabetes, AF, Acute MI, Unstable Angina, Bifurcation, VKA). The COBRA PzF stent is safe and effective in routine practice. These preliminary data and the rapid reendothelialization observed in preclinical will serve as an impetus for a multi-center randomized study of short DAPT.